R-010-002 Approved Suppliers List
- Governed by
GP-010 Purchases and suppliers evaluation
Purpose
General list of all approved suppliers, their type, criticality classification, and current approval status. This list is reviewed and re-evaluated annually during the Management Review.
Approved suppliers list
21
Total suppliers
7
CIV
14
NIV
7
Critical
| # | Code | Supplier Name | Service/Product | Type | Critical | Approval Date | Next Review | Status |
|---|---|---|---|---|---|---|---|---|
| 1 | S-AMA | Amazon Web Services, Inc | Cloud services (AWS) | CIV | Yes | 2025-01-13 | 2026-04-01 | Approved |
| 2 | S-ATL | Atlassian Corporation | Project management, code collaboration (Jira, Confluence, Bitbucket) | CIV | Yes | 2025-01-13 | 2026-04-01 | Approved |
| 3 | S-GOO | Google LLC | Google Workspace | NIV | No | 2025-01-13 | 2026-04-01 | Approved |
| 4 | S-PSC | PS Consulting | Regulatory and Quality services | NIV | No | 2025-01-13 | 2026-04-01 | Approved |
| 5 | S-AUD | Audens | Legal services | NIV | No | 2025-01-13 | 2026-04-01 | Approved |
| 6 | S-STR | Stripe, Inc | Payment processing | NIV | No | 2025-01-13 | 2026-04-01 | Approved |
| 7 | S-IDI | iDISC Information Technologies, S.L. | Translation services | NIV | No | 2025-01-13 | 2026-04-01 | Approved |
| 8 | S-LAW | Lawesome | Legal services | NIV | No | 2025-01-13 | 2026-04-01 | Approved |
| 9 | S-HUB | HubSpot, Inc. | CRM, Marketing | NIV | No | 2025-01-13 | 2026-04-01 | Approved |
| 10 | S-HOL | Holded Technologies | Accounting software | NIV | No | 2025-01-13 | 2026-04-01 | Approved |
| 11 | S-FAC | Factorial | HR management | NIV | No | 2025-01-13 | 2026-04-01 | Approved |
| 12 | S-SLA | Slack Technologies, Salesforce Inc | Team communication | NIV | No | 2025-01-13 | 2026-04-01 | Approved |
| 13 | S-APO | Apotech Consulting | Consulting services | NIV | No | 2025-01-13 | 2026-04-01 | Approved |
| 14 | S-BSI | BSI | Certification body | NIV | No | 2025-01-13 | 2026-04-01 | Approved |
| 15 | S-MIC | Microsoft | Development tools (GitHub, VS Code, Azure) | CIV | Yes | 2025-01-13 | 2026-04-01 | Approved |
| 16 | S-GLA | GL AI INVESTMENT | AI services | CIV | Yes | 2025-01-13 | 2026-04-01 | Approved |
| 17 | S-DOC | Docker, Inc. | Container platform | CIV | Yes | 2025-01-13 | 2026-04-01 | Approved |
| 18 | S-CMG | CMG MedDev | Regulatory consulting | NIV | No | 2025-01-13 | 2026-04-01 | Approved |
| 19 | S-DME | Dmed software | Medical device software services | CIV | Yes | 2025-01-13 | 2026-04-01 | Approved |
| 20 | S-DES | Design science | Design services | CIV | Yes | 2025-01-13 | 2026-04-01 | Approved |
| 21 | S-BRA | Brazil Import Healthcare Solutions | Distribution services | NIV | No | 2025-01-13 | 2026-04-01 | Approved |
Type definitions
- NIV: Non-Impact Vendor
- CIV: Controlled Impact Vendor
- NIS: Non-Impact Subcontractor
- CIS: Controlled Impact Subcontractor
- HRIV: High-Risk Impact Vendor (cannot be approved)
- HRIS: High-Risk Impact Subcontractor (cannot be approved)
Criticality
- Critical: Supplier directly impacts the safety, performance, or regulatory compliance of the medical device
- Non-critical: Supplier does not directly impact the medical device quality
Notes
- All CIV suppliers are considered critical as they directly impact development or production of the medical device
- Annual review scheduled during Management Review
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Team members involved
- Reviewer: JD-003 Design & Development Manager, JD-004 Quality Manager & PRRC
- Approver: JD-001 General Manager